BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE ANCHORAGE MTP / CROSS PLATE - RIGHT

    MDR report key: 5833537 · Received July 29, 2016

    Report

    Report Number
    0008031020-2016-00364
    Event Type
    Injury
    Date Received
    July 29, 2016
    Date of Event
    August 5, 2015
    Report Date
    December 29, 2016
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    PMA / PMN Number
    K083447
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT PLATE ANCHORAGE MTP / CROSS PLATE - RIGHT WAS ALLEGED OF 'IMPLANT BREAKAGE AFTER SURGERY' COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT SUCH AS THE PATIENT'S BONE QUALITY AND POST OPERATIVE ACTIVITY LEVEL, AS WELL AS THE AFFECTED DEVICE AND INFORMATION ABOUT IF THE SURGEON USED A PLATE BENDER WITH THE PLATE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA FDA MAUDE REPORT MW 5062947, HAD SURGERY, ARTHRODESIS AND FUSION SINGLE JOINT RIGHT TOE (1ST MTP FUSION). ALSO HAD EXCISION OF NEUROMA 2ND INNERSPACE RIGHT FOOT AT THE SAME TIME. THE FUSION NEVER HAPPENED, JUST HAD 2ND SURGERY WITH BONE GRAFT, SECOND SURGEON FOUND THE ORIGINAL PLATE BROKEN AND SCREWS LOOSE, WAS SENT TO PATHOLOGIST.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA FDA MAUDE REPORT MW 5062947, HAD SURGERY, ARTHRODESIS AND FUSION SINGLE JOINT RIGHT TOE (1ST MTP FUSION). ALSO HAD EXCISION OF NEUROMA 2ND INNERSPACE RIGHT FOOT AT THE SAME TIME. THE FUSION NEVER HAPPENED, JUST HAD 2ND SURGERY WITH BONE GRAFT, SECOND SURGEON FOUND THE ORIGINAL PLATE BROKEN AND SCREWS LOOSE, WAS SENT TO PATHOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485219 PLATE ANCHORAGE MTP / CROSS PLATE - RIGHT PLATE, FIXATION, BONE HRS STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention